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Data / Medical devices / Solid State X-Ray Imager (Flat Panel/Digital Imager)

Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB): 98 FDA-registered makers in 17 countries

98 establishments in 17 countries are registered with the FDA to make Solid State X-Ray Imager (Flat Panel/Digital Imager) (product code MQB, Class 2, 21 CFR 892.1680). 61 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 424 510(k) clearances under this code, the latest on July 31, 2026, and lists 113 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
MQB
Device class
2
Regulation
892.1680
Medical specialty
Radiology

Makers by country

CountryMakers
United States25
South Korea20
China14
Japan12
India5
Italy5
Germany4
Israel3
Canada2
Belgium1
Taiwan1
Spain1
Sweden1
Brazil1
Mexico1
Australia1
Netherlands1

Makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Rayence Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer30July 31, 2026000api.fda.gov
Canon Components, Inc.KODAMA-GUN Saitama, JapanManufacturer19October 17, 2022000api.fda.gov
Canon Inc.Kawasaki Kanagawa, JapanSpecification developer19October 17, 2022010api.fda.gov
Canon.IncOHTA-KU Tokyo, JapanSpecification developer19October 17, 2022000api.fda.gov
Konica Minolta, Inc.HINO-SHI Tokyo, JapanComplaint file establishment, Specification developer19June 17, 2025000api.fda.gov
Konica Minolta Technoproducts Co., Ltd.SAYAMA-SHI Saitama, JapanManufacturer18June 17, 2025000api.fda.gov
Konica Minolta, Inc.HACHIOJI-SHI Tokyo, JapanSpecification developer18June 17, 2025000api.fda.gov
Agfa N.V.Mortsel Antwerpen, BelgiumComplaint file establishment, Manufacturer, Specification developer17November 18, 2021000api.fda.gov
iRay GroupShanghai, ChinaComplaint file establishment, Manufacturer, Specification developer15February 3, 2023000api.fda.gov
Careray Digital Medical Technology Co., Ltd.SuZhou Jiangsu, ChinaManufacturer13August 3, 2023000api.fda.gov
DRTECH CorporationSeongnam-si Gyeonggi, South KoreaManufacturer13March 20, 2025000api.fda.gov
Agfa-Gevaert Healthcare GMBHPEISSENBERG Bavaria, GermanyManufacturer11November 18, 2021000api.fda.gov
Carestream Health, IncRochester, NY, United StatesComplaint file establishment, Manufacturer11October 9, 2025010api.fda.gov
Vieworks Co., Ltd.Anyang-si Gyeonggi, South KoreaComplaint file establishment, Exporter to the US, Specification developer11June 18, 2026000api.fda.gov
Vieworks Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer11June 18, 2026000api.fda.gov
Compass Innovations, IncSanta Clara, CA, United StatesManufacturer, Remanufacturer, Repackager or relabeler10December 30, 2022000api.fda.gov
Fujifilm CorporationASHIGARAKAMI-GUN Kanagawa, JapanComplaint file establishment, Manufacturer9April 10, 2020000api.fda.gov
LG Electronics Inc.Gumi-si Gyeongbuk, South KoreaExporter to the US, Manufacturer8July 22, 2022000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Hanamaki OfficeHANAMAKI-SHI Iwate, JapanManufacturer7April 10, 2020000api.fda.gov
Philips Medical Systems DMC GmbHHamburg, GermanyComplaint file establishment, Specification developer7September 30, 2020030api.fda.gov
Innocare Optoelectronics Corp.Tainan, TaiwanContract manufacturer, Manufacturer6July 22, 2025000api.fda.gov
Konica Minolta Healthcare Americas, IncGarner, NC, United StatesManufacturer6June 12, 2026000api.fda.gov
Philips India Limited - Diagnostic X-ray Business UnitBengaluru Karnataka, IndiaSpecification developer5September 30, 2020000api.fda.gov
Philips India Limited - Diagnostic X-ray Business UnitPimpri Maharashtra, IndiaSpecification developer5September 30, 2020000api.fda.gov
H&abyzYongin-si Gyeonggi, South KoreaContract manufacturer, Manufacturer4March 6, 2023000api.fda.gov
Radlink, Inc.El Segundo, CA, United StatesManufacturer, Repackager or relabeler4September 8, 2016000api.fda.gov
Samsung Electronics Co., Ltd.Seoul, South KoreaComplaint file establishment, Specification developer4July 20, 2018000api.fda.gov
Samsung Electronics Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer4July 20, 2018000api.fda.gov
Varex Imaging CorporationSalt Lake City, UT, United StatesManufacturer4December 20, 2019000api.fda.gov
Bontech Co., LtdSuwon-si Gyeonggi, South KoreaExporter to the US, Manufacturer3April 23, 2020000api.fda.gov
Canon Inc.OTAWARA-SHI Tochigi, JapanManufacturer3October 9, 2012000api.fda.gov
Canon Inc.OHTA-KU Tokyo, JapanSpecification developer3October 9, 2012000api.fda.gov
PixxGen CorporationAnyang-si Gyeonggi, South KoreaManufacturer3June 4, 2021000api.fda.gov
iCRco Inc.Goleta, CA, United StatesManufacturer, Repackager or relabeler3July 20, 2022000api.fda.gov
Biokinemetrics Inc.Carroll, IA, United StatesManufacturer2March 13, 2019000api.fda.gov
Del Medical, Inc.Bloomingdale, IL, United StatesManufacturer2July 17, 2014000api.fda.gov
GE Healthcare (China) Co., Ltd.Beijing, ChinaSpecification developer2November 18, 2010000api.fda.gov
Kub Technologies, Inc.Stratford, CT, United StatesManufacturer2June 23, 2015000api.fda.gov
Oehm Und Rehbein GMBHROSTOCK Mecklenburg-Western Pomerania, GermanyManufacturer2August 29, 2014000api.fda.gov
Pzmedical Technology Co., Ltd.Putuo District Shanghai, ChinaManufacturer2August 23, 2021000api.fda.gov
Radisen Co LtdAnyang Gyeonggi, South KoreaComplaint file establishment, Manufacturer2May 13, 2022000api.fda.gov
RadmediX, LLCDayton, OH, United StatesManufacturer, Repackager or relabeler2July 12, 2023000api.fda.gov
SG Healthcare Co LtdMoga-myeon, Icheon-si Gyeonggi, South KoreaManufacturer, Repackager or relabeler2July 7, 2017000api.fda.gov
A.T.S. Applicazione Tecnologie Speciali s.r.l.Torre de Roveri Bergamo, ItalyManufacturer1July 9, 2021000api.fda.gov
Aspen Imaging Healthcare, IncPlano, TX, United StatesManufacturer1February 14, 2020000api.fda.gov
Astel.incYuseong-gu Daejeon, South KoreaManufacturer1August 25, 2021000api.fda.gov
Carestream Health, Inc., Global R&D CenterShanghai, ChinaSpecification developer1October 16, 2019000api.fda.gov
Dentium Co.,ltd(ict Branch)Suwon Gyeonggi, South KoreaManufacturer1June 10, 2020000api.fda.gov
Digiray CorpDaejeon, South KoreaManufacturer1January 15, 2014000api.fda.gov
First Source Inc.Rochester, NY, United StatesSpecification developer1March 24, 2021000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu OfficeMINAMIASHIGARA-SHI Kanagawa, JapanManufacturer1August 25, 2004000api.fda.gov
FUJIFILM Imaging System (Suzhou) Co., Ltd.Suzhou Jiangsu, ChinaManufacturer1August 25, 2004000api.fda.gov
Ge Hangwei Medical Systems Co., Ltd.Beijing, ChinaManufacturer1November 18, 2010000api.fda.gov
Ge Medical Systems, LLCWaukesha, WI, United StatesManufacturer, Specification developer1November 17, 20060300api.fda.gov
JPI Healthcare Co., LtdSeoul, South KoreaComplaint file establishment, Exporter to the US, Manufacturer1February 24, 2025000api.fda.gov
Ka Imaging Inc.Waterloo Ontario, CanadaManufacturer1September 3, 2020000api.fda.gov
Medicatech UsaAnaheim, CA, United StatesManufacturer, Repackager or relabeler, Specification developer1September 1, 2023000api.fda.gov
Nical SPAMILAN (MI) Lombardy, ItalyManufacturer1January 6, 2006000api.fda.gov
Prognosys Medical Systems Private LimitedBengaluru Karnataka, IndiaManufacturer1November 12, 2024000api.fda.gov
Sedecal S.A.ALGETE Madrid(Province), SpainManufacturer1March 21, 2014010api.fda.gov
Shimadzu Corporation Medical Systems DivisionKyoto, JapanComplaint file establishment, Manufacturer1June 1, 2005000api.fda.gov
Arcoma ABVAXJO Kronoberg, SwedenManufacturer0000api.fda.gov
Accogent PauschEatontown, NJ, United StatesManufacturer0000api.fda.gov
Alliage S/A Industrias Medico OdontologicaRibeirao Preto Sao Paulo, BrazilManufacturer0000api.fda.gov
CMT Medical Technologies, Ltd.YOKNEAM ILLIT Northern, IsraelManufacturer0000api.fda.gov
Dentsply LLCYork, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Drgem CorporationGwangmyeong-si Gyeongbuk, South KoreaComplaint file establishment, Specification developer0000api.fda.gov
DRGEM Corporation (Gimcheon Factory)Gimcheon-si Gyeongbuk, South KoreaManufacturer0000api.fda.gov
Dagesh F.K. Ltd.Yad Binyamin Central, IsraelContract manufacturer0000api.fda.gov
Ge Medical Systems Monterrey Mexico, S.A. De C.V.APODACA Nuevo Leon, MexicoManufacturer0000api.fda.gov
General Medical Merate S.P.A.Seriate, Bergamo, ItalyManufacturer0000api.fda.gov
Halifax Biomedical Inc.Mabou Nova Scotia, CanadaManufacturer0000api.fda.gov
Iray Imaging LLCSolon, OH, United StatesContract manufacturer0000api.fda.gov
Iray Korea LimitedSeoul, South KoreaContract manufacturer0000api.fda.gov
Micro-X LtdTonsley South Australia, AustraliaManufacturer0000api.fda.gov
Minxray, Inc.Northbrook, IL, United StatesManufacturer0000api.fda.gov
Nano-X Imaging LtdPETAH TIKVA Central, IsraelManufacturer0000api.fda.gov
Omega Medical Imaging, LLCSanford, FL, United StatesManufacturer0000api.fda.gov
Orthoscan, Inc.Scottsdale, AZ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Philips Medical Systems Nederland B.V.BEST Noord-Brabant, NetherlandsContract manufacturer0000api.fda.gov
Philips Healthcare (Suzhou) Co., Ltd.Suzhou Jiangsu, ChinaComplaint file establishment, Specification developer0000api.fda.gov
Radiology Information Systems, Inc.Dulles, VA, United StatesManufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Shanghai United Imaging Healthcare Co.,ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shantou Institute Of Ultrasonic Instruments Co., Ltd.Shantou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shantou Institute Of Ultrasonic Instruments Co., Ltd.SHANTOU Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Siemens Shanghai, Medical Equipment Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Skanray Technologies LimitedMysore Karnataka, IndiaComplaint file establishment, Manufacturer0000api.fda.gov
Summit Industries, LLCNiles, IL, United StatesManufacturer0000api.fda.gov
Siemens Healthineers AGFORCHHEIM Bavaria, GermanyContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Source-Ray, Inc.Ronkonkoma, NY, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Vatech Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Villa Sistemi Medicali S.P.A.BUCCINASCO Milano, ItalyManufacturer0000api.fda.gov
WIPRO GE HEALTHCARE PRIVATE Ltd.BANGALORE Karnataka, IndiaSpecification developer0000api.fda.gov
Xline SRLASSAGO Milano, ItalyManufacturer0000api.fda.gov
Zentech Manufacturing, IncBaltimore, MD, United StatesContract manufacturer0000api.fda.gov
iRay Imaging Technology (Haining) LimitedHaining Zhejiang, ChinaContract manufacturer0000api.fda.gov
iRay Imaging Technology Taicang LimitedTaicang Jiangsu, ChinaContract manufacturer0000api.fda.gov

Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.